A Study to Evaluate the Efficacy and Safety of KH001 in Patients with Dentin Hypersensitivity

NCT ID: NCT06264453

Last Updated: 2025-03-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

171 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-19

Study Completion Date

2024-09-25

Brief Summary

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The purpose of this study is to evaluate the efficacy and safety of KH001 in patients with dentin hypersensitivity.

Detailed Description

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This study is multicenter, double-blind, placebo-controlled, randomized, parallel-designed, phase 2 study to evaluate the efficacy and safety of KH001. The total duration of the study will be approximately 7 to 11 weeks. Clinical safety evaluations will include physical examinations, vital signs, clinical laboratory results, and Adverse Event monitoring.

Conditions

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Dentin Hypersensitivity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Group A

KH001 0.2mg/mL

Group Type EXPERIMENTAL

KH001

Intervention Type DRUG

topical applications of KH001

Group B

KH001 0.4mg/mL

Group Type EXPERIMENTAL

KH001

Intervention Type DRUG

topical applications of KH001

Group C

Water for Injection

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

topical applications of Water for Injection

Interventions

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KH001

topical applications of KH001

Intervention Type DRUG

Placebo

topical applications of Water for Injection

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Is at least 19 years old by the time of the screening visit
* Be in good general health as determined by the investigator
* Have at least 2 non-adjacent teeth and is diagnosed with hypersensitive

Exclusion Criteria

* Is allergic to the active drug substance or other excipients used in the investigational product
* Has any history of alcohol or drug abuse
* Has received any treatment related to dentin hypersensitivity within 8 weeks prior to the screening visit
* Has active dental caries or history of dental caries
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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HysensBio Co., Ltd

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kyoung-Kyu Choi, D.D.S

Role: PRINCIPAL_INVESTIGATOR

Kyung Hee University Dentistry Hospital

Locations

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Kyung Hee University Dental Hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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KH-001-D201

Identifier Type: -

Identifier Source: org_study_id

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